Posted on 12/28/2004 2:47:28 PM PST by neverdem
Filed at 4:45 p.m. ET
WASHINGTON (AP) -- The government approved a drug Tuesday that offers a new way of fighting severe pain -- an option for patients who no longer benefit from morphine and other traditional pain medications.
It's the first in a new class of drugs that selectively blocks the nerve channels responsible for transmitting pain signals. It will be marketed as Prialt and should be available by the end of January.
``When you've taken all the kinds of pain medication that there is and you still have pain, that is a very frightening situation,'' said Dr. Lars Ekman, president of research and development for the drug's Ireland-based manufacturer, Elan. ``When you have that kind of pain, there is nowhere to go.''
The drug is part of a new class known as N-type calcium channel blockers. It is known chemically as ziconotide.
Morphine is the standard treatment for severe pain from cancer, AIDS, amputations and other significant illnesses, but its effects eventually wear off and the dosage must be increased. At some point, many patients switch from taking medication by mouth or by injection to a microinfusion pump implanted under the skin that delivers drugs directly into the fluid surrounding the spinal cord.
Ekman said about 35,000 to 50,000 Americans have these pumps now. The Food and Drug Administration approved Prialt for patients who are already using these pumps but not getting effective relief from them or who cannot tolerate the available treatments.
This is the first new drug in 20 years to treat pain using such a pump.
Prialt has been studied in patients with cancer, AIDS and other chronic pain, such as back pain. More than 1,200 patients took part in three clinical trials.
There are side effects, and the FDA was including a ``black box'' warning -- the government's strongest warning short of a ban. Side effects may include dizziness, drowsiness and altered mental status, with patients confused at times.
Despite the side effects, the drug was approved because there are no other options for these patients and the benefits outweighed the risks, said Dr. Robert Meyer, director of the FDA's Office of Drug Evaluation II.
``Because this is such an important patient population where they have such pain and they have so few options we felt this drug does offer some real gains,'' he said.
Patients with a history of psychoses should not receive it, and all others should be monitored for signs of cognitive impairment, he said.
The idea for the drug came from a snail called the Conus magus that lives in the South Pacific, which paralyzes its victims with venom after capturing them, the company said. Researchers set out learning how to develop a drug based on this venom and eventually copied the amino acid sequence.
Elan would not say how much it plans to charge for the drug.
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On the Net:
FDA: http://www.fda.gov
Elan: http://www.elan.com
Hey Marcus, ever been "nerved" before? I have. It's when they cut the nerves to a joint in order to give you pain relief. Of course you lose function, but it's sometimes the only choice.
As someone (me) who takes anti-inflamatory medication for chronic pain, I can say you don't even not what you are talking about.
Americans worship pills like the higher god. It's insane. Good marketing though......
Americans worship pills as much as they do their eye-glasses, they are just tools to make going through one's daily life easier.
Now the REAL problem on this issue is drug companies charging us U.S. citizens THREE TIMES the price in medicine they do to the rest of the world.
P.S. My name is Paul C. Jesup, not Marcus.
As for the costs of prescription medications....The rest of the world does not have an Insurance/HMO industry that's as fat as the universe is expanding, while we feed it like it's a bulemic at an all it can eat buffet. When the average working person pays a grand a month for health insurance(thru an employer), that money has to go somewhere........
I like the idea of MSA's and self purchased insurance which only kicks in after $10,000 per year of medical expenses. You still come out ahead and if we started paying cash for healthcare, the costs would free-fall.
And I'm sorry for the Marcus Welby thing......But you know nothing of my life either.
So you worship you eye-glasses, too!! 0_0
And since government created HMO's and created the problems with drug compamies with patent monopolies, it is goverment that is to blame.
Good Lord, man, you're a walking mess!!!
No, I do not worship my eyeglasses, I do however worship the surgeon who rebuilt my orbital platform which acts as a place for my eyeball to reside with reasonable stability. For a while there, all I could see out the left side was the ceiling.
Anytime you get into a thread on prescription pills and drugs, it draws the same lines of logic. Both have their valid points, but it's limited to a crowd with bias and a dog in the fight. Truth is, we're both right and based on experiences gained by a relative few. It's not a reality of an internet forum. Case by case is not good public policy.
Patent monopolies????? Uhmmmmm.....Never mind! My wife is a chemical researcher and I won't even begin to explain product development costs. An eighteen year capture on cost recovery is quite reasonable. Not to mention you can always take a patented existing drug and modify it in a meaningful way and then market it as a competitor. Take Augmentin as an example. Link an acid chain to a patented antibiotic from company A and company B now has rights as well! It also works hundreds of times better than company A's product, now almost worthless.
The explains you opinions, but surgery is usually a last resort because it is more risky compared to using medication AS IT IS INTENDED.
No wonder you are only complaining about only the insurance industries and not about the drug companies, you have a personal vested interest in the drug companies inflated pricing structure.
HMO coverage is NOT HEALTH INSURANCE! It's a bargain contract in which many rights are tossed out to the dope signing it. All the rights are with the company issuing the contract.
My wife does nothing in drug research. She makes stuff work better in industry. I just know the patent issues. They are universal.
But by having HMO's uncutting the price of insurance, you have insurance companies rising their rate to cope. But by that same token, insure is an inflationary factor on prices as a whole, whether it is car insurance, home insurance or medical insurance.
If she works in the industry, then she and you have a vested interest in that industry.
Question..........When NFL or sports figures have a chronic injury or pain condition, how do they correct it as quickly and effectively as possible?
FRICKEN SURGERY!!!!! Sure there are post surgery meds, but they do surgery to correct stuff. Taking pills does not correct anything but mask it. I offer you the same argument on vision correction surgery which makes eyeglasses and corrective lenses obsolete. As vision technology surges forward, general medicine and surgery goes backwards. Funny huh?
So I guess I have a vested dynasty in making paper towels and toilet paper.............OK!
It's quite obvious I am a market force kind of person and you are a regulatory gubmint price control kind of person. Not better or worse, just philosophicaly different. Merits are for the record.
Are you implying that all chemical research is related to the drug industry? OMG!
Hospital closings can be blamed on a lot of things; goverment regulations & taxations, lawsuits, illegal immigrants, a corrupt press, drug companies, and insurance from both the doctor's end and the patient end.
Are you implying that all chemical research is related to the drug industry? OMG
What do you think medicines are, they are chemicals.
You and I need a drug to deal with the long term chronic pain of this thread.
The little cell sent by your daddy that poked your mommy's ripe egg did so only because it used chemicals to win the race. The whole world as you know it is nothing but one big chemical circus.
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